Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01346358 · ClinicalTrials.gov registry record · Phase 1

A Study of IMC-CS4 in Subjects With Advanced Solid Tumors

A Phase 1 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target

NCT01346358: Completed Phase 1 study, sponsored by Eli Lilly and Company.

NCT01346358 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01346358, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target

Study Summary

A dose escalation study to establish the safety profile and characterize the pharmacokinetic profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available.

Primary Outcome

Pharmacokinetics (PK) - Maximum concentration (Cmax) of IMC-CS4.

Interventions

  • BIOLOGICAL IMC-CS4

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2011-06-15
Est. Completion 2018-05-31
Phase Phase 1
Eli Lilly and Company

1,341 total trials

What the finished NCT01346358 record still lists

NCT01346358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).

The record links to 0 conditions, and to 1 intervention - of which IMC-CS4 is the first listed.

NCT01346358 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01346358 about?

NCT01346358 is a clinical study titled "A Study of IMC-CS4 in Subjects With Advanced Solid Tumors". A dose escalation study to establish the safety profile and characterize the pharmacokinetic profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available.

What is the current status of trial NCT01346358?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2011-06-15. Estimated completion is 2018-05-31.

What interventions are being tested in trial NCT01346358?

The interventions under investigation include: IMC-CS4 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01346358?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01346358's enrollment target sits among peer trials

52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02630121 · 52 participants · Phase 4

    Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea

  • NCT03629171 · 52 participants · Phase 2

    Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia

  • NCT04128748 · 52 participants · Phase 1

    Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

  • NCT04150497 · 52 participants · Phase 1

    Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT01346358, the US trial registry maintained by the National Library of Medicine. NCT01346358 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.